Drug Addiction Clinical Trial
Official title:
Homeless Female Offenders Returning to the Community: Improving Hopeful Futures
In Phase I of this R34, the team from the University of California Los Angeles, San
Francisco, and Irvine researchers plan to utilize the successful community participatory
approaches to refine a gender-sensitive criminogenic needs -focused intervention program,
Female Ex-Offender Mentoring in Care (FEM-CARE), with the help of a community advisory
board, composed of homeless female offenders (HFOs) and addiction staff; and finalize
strategies which will be validated by focus group sessions with the HFOs. In Phase 2, the
research team will randomize 130 HFOs participating in one of two residential drug treatment
programs to assess the impact of the FEM-CARE or a Health Promotion control program on
reduction of drug and alcohol use and recidivism. This study is based upon our team's
history of promoting theoretically-based, culturally sensitive nurse-led interventions that
are enriched with criminal justice theoretical perspectives, and have resulted in
significant reductions in drug and alcohol use among homeless persons, many of whom have had
a history of incarceration.
Specifically, the study aims are:
AIM 1) Guided by a Community Advisory Board (CAB) made up of HFOs and addiction staff,
further conceptualize our community-based program, Female Ex-Offender Mentoring in Care
(FEM-CARE), to address the needs and risks of HFOs enrolled in RDT programs, and then refine
the program in focus group discussions with 12 HFOs.
AIM 2) Conduct a pilot RCT to assess the impact of the FEM-CARE program for 65 HFOs at
six-month follow-up compared with 65 HFOs receiving a control Health Promotion (HP) program,
in terms of a) self-reported and/or objective measures of drug and alcohol use; and b)
prevalence of recidivism and number of days to first reincarceration.
Hypothesis 2a: HFOs in the FEM-CARE program will have less drug and alcohol use at six
months than HFOs in the HP control program.
Hypothesis 2b: FEM-CARE HFOs will have a lower prevalence of recidivism by six months and
greater number of days to first reincarceration than HP control HFOs.
In the last decade, the numbers of incarcerated females has tripled, making women the most rapidly growing group of offenders in the United States. When compared to incarcerated males, female offenders have a higher rate of being sentenced for drug crimes; moreover, they are often injection drug users (IDUs), have sexual partners who are IDUs, and are often forced into the sex trade for survival. As many as 50% of female offenders report physical and/or sexual abuse; further, traumatic abuse, chronic emotional distress, and internalized stigma resulting from being a felon and a drug-user, have a profound effect on the women's self-esteem, leading to feelings of hopelessness and depression, delayed recovery and reintegration, increased risky behaviors, and health concerns. Not surprisingly, women who have been incarcerated are nearly twice as likely to experience mental illness compared with non-offending women; further, 44% recidivate within a year due to possession of a controlled substance. In particular, among homeless female offenders (HFOs), both parolees and probationers report ongoing challenges for successful re-entry. These include unstable housing, disorganized lives, unemployment, and limited access to health and social services. While the Los Angeles County Department of Probation has provided guidance for successful programs in its California Blueprint Master Plan for Female Offenders, the suggested strategies of enhancing empowerment, positive coping, and job skills, and providing peer-mentored approaches have not yet been implemented or evaluated. In Phase I of this R34, our team of University of California Los Angeles, San Francisco, and Irvine researchers plan to utilize our successful community participatory approaches to refine a gender-sensitive criminogenic needs -focused intervention program, Female Ex-Offender Mentoring in Care (FEM-CARE), with the help of a community advisory board, composed of HFOs and addiction staff; and finalize strategies which will be validated by focus group sessions with HFOs. In Phase 2, we will randomize 130 HFOs participating in one of two residential drug treatment programs to assess the impact of the FEM-CARE or a Health Promotion control program on reduction of drug and alcohol use and recidivism. This study is based upon our team's history of promoting theoretically-based, culturally sensitive nurse-led interventions that are enriched with criminal justice theoretical perspectives, and have resulted in significant reductions in drug and alcohol use among homeless persons, many of whom have had a history of incarceration. Our most recent successes in engaging male parolees in nurse-supported peer mentorship, our team's expertise in enhancing stigma reduction among vulnerable women, and our criminal justice experts have informed this study. Finally, recent formative research with HFOs has revealed a desire for peer role models to support and enhance knowledge of and access to healthcare, promote positive coping, stable housing, and job skills, and to reduce stigma and depressed mood; all of these factors can result in novel programs designed to prevent drug and alcohol use and reduce recidivism. This foundation and strong community support garnered has led to the design of our proposed intervention program. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02939352 -
The Effects of Theta Burst Stimulation on the Brain Response to Drug and Alcohol Cues
|
Early Phase 1 | |
Completed |
NCT02282306 -
Phone Interview to Prevent Recurring Opioid Overdoses
|
N/A | |
Completed |
NCT02224508 -
Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks
|
N/A | |
Completed |
NCT02437123 -
The Cedar Project: Impact of mHealth for HIV Prevention Among Young Indigenous People Who Use Illicit Drugs
|
N/A | |
Completed |
NCT02192931 -
A Randomized Double-Blind Controlled Trial of Creatine in Female Methamphetamine Users
|
Phase 4 | |
Completed |
NCT01685073 -
The Role of Sleep in the Treatment of Cannabis Use Disorders
|
Phase 2/Phase 3 | |
Completed |
NCT01591239 -
Home-Based Program to Help Parents of Drug Abusing Adolescents
|
N/A | |
Completed |
NCT00317460 -
Buprenorphine and Integrated HIV Care
|
Phase 4 | |
Completed |
NCT03678051 -
CBT4CBT for Women in Residential Treatment for Substance Use Disorders
|
N/A | |
Completed |
NCT04105621 -
Westlake Personalized Nutrition and Health Cohort for Drug Addicts
|
||
Withdrawn |
NCT05440721 -
Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification
|
N/A | |
Completed |
NCT03694327 -
Innovative Digital Therapeutic for Smoking Cessation
|
N/A | |
Completed |
NCT00244699 -
Integrating Mindfulness-Based Skills Training Into Brief Outpatient Treatment for Substance Abusing Youth
|
N/A | |
Completed |
NCT00496990 -
Treating the Partners of Drug Using Pregnant Women: Stage II
|
Phase 2/Phase 3 | |
Completed |
NCT00390559 -
Examining the Effect of the Nicotine Patch in Male and Female Smokers - 3
|
N/A | |
Completed |
NCT03402672 -
AWAITS: A Web-based E-health Application for Active Illicit Opioid Users
|
N/A | |
Completed |
NCT03411265 -
RETAIN: Retaining Opioid Users Entering Medication Assisted Treatment and Encouraging HCV/HIV Testing
|
N/A | |
Completed |
NCT01003496 -
Comparing Acute and Continuous Drug Abuse Treatment: A Randomized Clinical Trial
|
Phase 3 | |
Completed |
NCT02091284 -
Bilateral Prefrontal Modulation in Alcoholism
|
N/A | |
Completed |
NCT02091167 -
Bilateral Prefrontal Modulation in Crack-cocaine Addiction
|
Phase 2 |